Health Condition 1: G409- Epilepsy, unspecified
Conditions
Interventions
None listed
Sponsors
Namrata Hempco Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects with epilepsy history, ranging in age from 18 to 45 years. 2.Willingness to follow the protocol requirements as evidenced by written, informed consent. 3.Mentally, physically and legally eligible to give informed consent 4.Willingness to complete study questionnaires
Exclusion criteria
Exclusion criteria: 1.Patients with pre-existing other severe systemic disease necessitating long-term medication. 2.Significant medical or psychiatric illness 3.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ 4.Any vascular or systemic disorder which could affect any of the efficacy assessments 5.Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month 6.Subjects received other medication (anti-viral) within the 36 hours before entry into the study 7.Patients who had immunization against influenza or influenza like illnesses for that season. 8.Inability to comply with the study protocol, including psychiatric diseases 9.Immune compromised or with other clinically active illness including cardiac or pulmonary diseases, hemoglobinopathies, renal dysfunction 10.Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 months before 11.Other reasons that researchers think not fitting to participate in the study 12.Evidence of significant uncontrolled comorbid disease which in the investigator opinion would jeopardize patient participation 13.Patient tested positive with Covid 19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to End of the Study in the Electroencephalogram Spike ActivityTimepoint: Day 0, Day 21, Day 42, Day 90, Day 120, Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs)Timepoint: Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180;Number of attacks before and after treatmentTimepoint: Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180;Percentage of patients reduced the attacks to nil by the end of the treatment periodTimepoint: Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180;SGA/PGATimepoint: Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180;Time to recover after onset of seizuresTimepoint: Day 0, Day 21 and Day 42, Day 90, Day 120 and Day 180 | — |
Countries
India
Contacts
Public ContactMr Harshavardhan Reddy Sirupa
Namrata Hempco Limited
Outcome results
None listed